DORO LUNA® Retractor System
GUDID 04250435519608
DORO LUNA® Standard Retractor System & DORO® QR3 Skull Clamp consisting of: 1001.001 1203.001 1203.002 1203.003 1203.004 1203.00
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Skull clamp| Primary Device ID | 04250435519608 |
| NIH Device Record Key | fcaf25fb-b7d1-4d4e-9b78-df929b8c5f2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DORO LUNA® Retractor System |
| Version Model Number | 1203.110 |
| Company DUNS | 313517922 |
| Company Name | pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250435519608 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K001808
FDA Product Code
| HBL | Holder, Head, Neurosurgical (Skull Clamp) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
[04250435519608]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [DORO LUNA® Retractor System]
| 04250435519639 | DORO LUNA® Compact Retractor System & DORO® QR3 Headrest System consisting of: 3116-151 |
| 04250435519622 | DORO LUNA® Compact Retractor System & DORO® QR3 Skull Clamp consisting of: 3116-151 3116 |
| 04250435519615 | DORO LUNA® Standard Retractor System & DORO® QR3 Headrest System cons |
| 04250435519608 | DORO LUNA® Standard Retractor System & DORO® QR3 Skull Clamp consisting |
| 04250435519356 | DORO LUNA® Retractor System - Compact System consisting of: |
| 04250435519349 | DORO LUNA® Retractor System - Standard System consisting of: 1203.001 |
Trademark Results [DORO LUNA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DORO LUNA 79151056 4929538 Live/Registered |
pro med instruments GmbH Herstellung un 2014-06-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.